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Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR) (NAVIGATOR)

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ClinicalTrials.gov Identifier: NCT03570671
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2018)
Safety and Tolerability [ Time Frame: 3 days ]
MDCTA procedure: all subjects will undergo MDCTA without a vasodilator ("initial CT") in the early morning before the ergonovine provocation spasm test. Subsequent "IV nitrate CT" will be allowed at a 3-day washout period after the first contrast usage. The scan protocol for the IV nitrate CT is as follows: during continuous injection of the intravenous vasodilating agent (isosorbidedinitrate 2 mg/hr), blood pressure will be checked every 2 minutes. When both the systolic and diastolic blood pressure decrease by 10 mmHg in comparison to the initial value, the CT scan initiate and images will be acquired during the nitrate infusion. Investigators define the positive criteria for VSA on MDCTA as follows:
  1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or
  2. Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03570671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2018)
  • Coronary vessel distensibility [ Time Frame: 3 days ]
    To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA
  • Cutoff value of coronary vessel distensibility index [ Time Frame: 3 days ]
    To consider the cutoff value of coronary vessel distensibility index (CVDI) to predict the coronary spasm induced angina-like attacks. Investigators define the CVDI as following formulas:
    1. CVDI-CSA (cross-section area)= [(CSA_IV nitrate - CSA_initial) / CSA_IV nitrate]ⅹ100% or
    2. CVDI-D (diameter)= [(D_IV nitrate - D_initial) / D_IV nitrate]ⅹ100%.
  • Incidence of multi-vessel spasm [ Time Frame: 3 days ]
    To examine the incidence of multi-vessel coronary spasm by MDCTA.
  • Diagnostic accuracy of MDCTA [ Time Frame: 3 days ]
    To determine the diagnostic accuracy of MDCTA modalities for detection of VSA.
  • Characteristics of spasm-related coronary artery segment [ Time Frame: 3 days ]
    To describe the characteristics of spasm-related coronary artery segment including vessel remodeling, plaque composition and stenosis degree.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry (NAVIGATOR)
Official Title  ICMJE Dual-acquisition of Noninvasive Cardiac Imaging in Vasospastic Angina Korean Registry
Brief Summary

With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia.

Presently available imaging test for coronary artery disease in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.

Detailed Description

Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%.

Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control.

Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Spasm
Intervention  ICMJE
  • Diagnostic Test: Spasm positive

    Investigators define the positive criteria for VSA on MDCTA as follows:

    1. Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or
    2. Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT.
  • Diagnostic Test: Spasm negative
    Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.
Study Arms  ICMJE
  • Experimental: Spasm positive
    Ergonovine-induced coronary spasm provocation test positive: defined as transient, total, or sub-total occlusion (>90% stenosis) of a coronary artery with symptoms of myocardial ischemia (angina pain and ischemic ECG change).
    Intervention: Diagnostic Test: Spasm positive
  • Placebo Comparator: Spasm negative
    Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality.
    Intervention: Diagnostic Test: Spasm negative
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is onset of angina-like attack at rest, during effort, or during rest and effort.
  • Subject has chest pain between night and early morning.
  • Subject is scheduled to undergo MDCTA.
  • Subject is an acceptable candidate for CAG with an EG provocation test.
  • Cardiac condition: BP>90/60mmHg, ECG: sinus rhythm with regular, left ventricular ejection fraction>55%, and resting heart rate<100 beats/min.
  • Subject will be provided written informed consent.
  • Subject is willing to comply with study follow-up requirement.

Exclusion Criteria:

  • Subject has clinical evidence of acute coronary syndrome.
  • Subject has evidence of significant narrowing (>50% stenosis by CAG).
  • Subject has clinical evidence of cardiomyopathy or valvular heart disease.
  • Subject is hemodynamically unstable.
  • Subject has a history of PCI and CABG.
  • Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
  • Subject has known allergy to contrast medium.
  • Subject has renal insufficiency (serum creatine >2.5 mg/dl).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Moo Hyun Kim, MD +82-51-240-2976 kimmh@dau.ac.kr
Contact: Cai De Jin, MD +86-178-0250-2582 jincaide1118@163.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03570671
Other Study ID Numbers  ICMJE NAVIGATOR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Moo Hyun Kim, Dong-A University
Study Sponsor  ICMJE Dong-A University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moo Hyun Kim, MD Dong-A University Hospital
PRS Account Dong-A University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP